Head and neck paragangliomas (HNPGs) are predominantly non-secreting, benign and slow-growing tumors. Although most patients remain asymptomatic, up to 30% develop symptoms related to local tumor growth and fewer than 5-10% develop metastatic disease. Surgery has long been considered the standard treatment, while radiotherapy and active surveillance represent alternative management strategies. Treatment-related morbidity and impaired quality of life have been reported in patients with HNPGs; however, the impact of immediate intervention compared with an initial active surveillance strategy has not been prospectively evaluated. This multicenter randomized controlled trial aims to compare active surveillance with immediate intervention in patients with newly diagnosed carotid or vagal paragangliomas. The study hypothesis is that an initial active surveillance strategy increases the time before functional outcome deterioration, particularly ENT-related symptoms, while not resulting in a higher complication rate when treatment is subsequently performed. Eligible patients will undergo baseline assessment including a specialized ENT examination to evaluate cranial nerve function and cervical MRI (or contrast-enhanced CT when MRI is contraindicated) to confirm tumor location, size, and the absence of lymphadenopathy or atypical imaging features. After providing written informed consent, participants will be centrally randomized in a 1:1 ratio, stratified by study center and tumor location, to either active surveillance or immediate intervention. Patients assigned to active surveillance will undergo regular clinical and radiological follow-up, with treatment initiated only if disease progression or symptom development warrants intervention. Patients assigned to immediate intervention will receive surgery or radiotherapy according to multidisciplinary team recommendations and local practice, within six months after randomization. Patients who decline participation in the randomized trial, as well as those who are not eligible for randomization, may be offered participation in a parallel observational study collecting clinical, imaging, treatment and outcome data according to routine practice. Patient quality of life will also be assessed throughout the study (experimental and observational) using validated questionnaires.
Patients ≥ 18 years-old,
Diagnosis of carotid or vagal HNPG with a largest diameter more than 10 mm
Diagnosis confirmed by imaging reading (MRI of CT scan) from less than 6 months,
Study eligibility validated in multidisciplinary discussion,
Patient with initial nerve palsy due to the evaluated HNPG,
Patient with non-typical presentation suggestive of aggressiveness (tumor pain, atypical imaging, suspicious lymphadenopathy),
Malignant HNPG identified by extra cervical lesion on metabolic imaging,
More than one HNPG at inclusion
Parallel
Active follow-up
Other interventionPatients will not receive any treatment, they will undergo annual follow-up assessments according to the standard of care. Upon disease progression, patients will be allowed to switch to the treatment group.
Surgery
Procedure/SurgeryPatients may be treated with surgery to remove the paraganglioma within 6 months after randomization.
Radiation
RadiationPatients may be treated with radiation within 6 months after randomization.
Time to functional outcome deterioration
Time to functional outcome deterioration is defined as the delay between inclusion and functional outcome deterioration. Patients without functional deterioration are censored at their last functional assessment. Functional outcome deterioration is defined as a decrease in at least 12 points (or 8.6%) of the FACT H\&N score since inclusion. The FACT-H\&N score ranges from 0 to 148. The higher the score, the better the quality of life.
Evolution of the functional outcomes between the groups
Functional outcomes are defined by the overall score of the FACT H\&N in both groups. The FACT-H\&N score ranges from 0 to 148. The higher the score, the better the quality of life.
Evolution of the functional outcomes between the groups
Functional outcomes are defined by the overall score of the EORTC QLQ-HN43 in both groups. The scores of the EORTC QLQ-HN43 module are standardized on a scale from 0 to 100. For all symptom scales, a higher score reflects greater symptom burden and poorer quality of life.
Quality of life (QoL)
Change on QoL in both groups assessed by the global health status score of the EORTC QLQ-C30. The scores of the EORTC QLQ-C30 questionnaire are standardized on a scale from 0 to 100. A higher score reflects a better level of functioning and a better quality of life.
Anxiety
Change on the anxiety evaluation in both groups assessed by HAD scale. The higher the score, the greater the severity of anxiety or depressive symptoms. The total score ranges from 0 to 42.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
